BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 1120766 · Received August 15, 2008

    Report

    Report Number
    3004209178-2008-04970
    Event Type
    Injury
    Date Received
    August 15, 2008
    Date of Event
    February 14, 2008
    Report Date
    July 21, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXTENSION AND LEAD WERE RETURNED TO THE MFR FOR ANALYSIS IN 2008. NEUROSTIMULATOR EVAL: FOREIGN MATERIAL WAS FOUND UNDER THE CONNECTOR COVER. THERE WAS NO ANOMALY FOUND WITH THE DEVICE. THE NEUROSTIMULATOR WAS FUNCTIONALLY OK. EXTENSION EVAL METHOD & CONCLUSIONS: DEVICE ANALYSIS OF THE EXTENSION REVEALED THAT ALL THE CONDUCTOR WIRES WERE BROKEN CORRESPONDING TO AN AREA OF PINCHED OUTER INSULATION.

    Description of Event or Problem · 1

    THE PT FELT A SURGING SENSATION. THE NEXT DAY SHE HAD A HEADACHE AND FELT NO STIMULATION SENSATION. THE IMPLANTABLE NEUROSTIMULATOR MAY HAVE SHIFTED IN THE POCKET. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE COMPLAINT. ON/OFF OPTIONS WERE REVIEWED WITH THE PT. THE PT WAS AT HOME AT THE TIME OF THE COMPLAINT AND HER STATUS WAS REPORTED AS "GOOD". THE PT WAS SEEN IN CLINIC THE SAME DAY. IMPEDANCES WERE GREATER THAN 3600 OHMS ON ALL 4 ELECTRODES. AN X-RAY WAS TAKEN. THERE WAS A POSSIBLE EXTENSION OR LEAD FRACTURE RELATED TO POSITIONING DIFFICULTIES. APPROX TWO WEEKS LATER THE PT HAD SURGICAL EXPLORATION OF THE SYS. THE IMPLANTABLE NEUROSTIMULATOR WAS COMPROMISED BY A BODY FLUID SHORT. THE EXTENSION AND NEUROSTIMULATOR WERE REPLACED THE SAME DAY. THE NEUROSTIMULATOR WAS REPOSITIONED ON HER RIGHT HIP. TWO MONTHS AFTER REPLACEMENT THE PT FELT MUCH BETTER AND HAD GOOD COVERAGE. THE HCP REPORTED THE PT OUTCOME AS 'NO INJURY, RECOVERED WITHOUT SEQUELA'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME ADVANCED LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention EXPLANTED| EXTENSION MODEL 37083 LOT # NKC010583N IMPLANTED| LEAD MODEL 3587A LOT # N087134 IMPLANTED| EXPLANTED